510(k) Report

510(k) · Cleared

Recalled · 2012

Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I

K034055510(k) SpecialCleared Jan 21, 200422-day reviewClass II21 CFR 862.1215Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Products Corp. · JHX Fluorometric Method, Cpk Or Isoenzymes

Cleared on Jan 21, 2004 as substantially equivalent to K022118 (Diagnostic Products Corp., 2002) and 2 other predicates after a 22-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.

Decided
Jan 21, 2004
Review
22 days
Class
Class II
Product code
JHX
Recalls
1
Predicates
3

Its longest line of descent runs back 2 generations to K004002 (2001). 4 ancestors in all, the oldest K991796 (1999). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestorsK004002 · Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 CK-MB, Model L2KMB2 (200 Tests), L2KMB6 (600) · Diagnostic Products Corp. · 2001 · recalledK022118 · Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests) · Diagnostic Products Corp. · 2002 · recalled199619982000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K022118 · Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests) · Diagnostic Products Corp. · 2002 · recalledK004002 · Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 CK-MB, Model L2KMB2 (200 Tests), L2KMB6 (600) · Diagnostic Products Corp. · 2001 · recalled0
  1. Root · 2 generations backK004002 Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite…Diagnostic Products Corp. · 2001 · Recalled
  2. 1 generation backK022118 Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)Diagnostic Products Corp. · 2002 · Recalled
  3. This deviceK034055 Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K004002Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000…Diagnostic Products Corp.20012
−1K022118Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)Diagnostic Products Corp.20021
0 (this device)K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
FIG. 1 — Lineage of K034055, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JHX device

  1. #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K022118Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)
Summary page 2
…3 42 Substantially Equivalent Predicate Device: IMMULITE/IMMULITE 1000 Turbo CK-MB (K022118) Description of Device: IMMULITE 2500 CK-MB is a solid-phase, two-site chemil…
Diagnostic Products Corp.20021
*K991796Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5
Summary page 4
…stantially Equivalent 45 Predicate Device: IMMULITE/IMMULITE 1000 Turbo Myoglobin (K991796) Description of Device: IMMULITE 2500 Myoglobin is a solid-phase, two-site chem…
Diagnostic Products Corp.1999—
*K991795Immulite Turbo Troponin I, Models LSKTI1, LSKTI5
Summary page 6
…stantially 48 Equivalent Predicate Device: IMMULITE/IMMULITE 1000 Turbo Troponin I (K991795) Description of Device: IMMULITE 2500 STAT Troponin I is a solid-phase, two-site…
Diagnostic Products Corp.19991

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 25, 2012Not classifiedZ-1274-2012Nonconforming Material/ComponentSiemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
  • 3 of the 4 ancestors have a recall of any class.

How does its category compare?

All JHX devices

JHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHX

1in 2024

2009: 12012: 12017: 12022: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHX

Too few JHX 510(k)s in any year since 2007 to give a median.

Recalls per year · JHX

2in 2015

2008: 12009: 12012: 42015: 2
2007high 4 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JHX

1in 2025

2007: 22008: 62009: 402010: 272011: 42012: 182013: 82014: 172015: 82016: 102017: 32018: 162019: 72020: 32021: 102022: 22023: 22024: 22025: 1
2007high 40 (2009) · low 1 (2025)2025

MAUDE reports naming product code JHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—16
20091—140
20100—027
20110—04
20121—418
20130—08
20140—017
20150—28
20160—010
20171—03
20180—016
20190—07
20200—03
20210—010
20221—02
20230—02
20241—02
20250—01
20260—0—

What is it indicated for?

The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as…

Read the full statement (125 words)

The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

Indications for use as stated in the FDA summary.

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002
  • K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLDiagnostic Products Corp. · 20021 recall

Recent decisions in JHX

The JHX category page

  • K234005Access CK-MBBeckman Coulter, Inc. · 2024
  • K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal CartridgeRadiometer Medical Aps · 2012
  • K081360Pathfast CK-MB-II, Pathfast Myo-IIMitsubishi Kagaku Iatron · 20091 recall

https://510kreport.com/device/K034055 · printed Nov 5, 2026

Cite this page

510(k) Report. “K034055: Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034055

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026